Doctors 'not told how dangerous vaginal mesh can be for women', BBC Panorama investigation reveals

Scores of women have reportedly been left in pain due to the routine operation.
David Jones/PA Wire
Alexandra Richards11 December 2017

Doctors were not informed of potential health risks from vaginal mesh implants, a shocking Panorama investigation has revealed.

The BBC programme, which is due to air on Monday, will claim to show how the distributor of vaginal mesh in the UK, Ethicon, did not tell doctors about the full extent of the risks surrounding the its mesh.

The vaginal implant – known as trans-vaginal tape (TVT) – is a small mesh support used to treat urinary incontinence or prolapse occurring after childbirth.

Risks linked to the implant are nerve damage, chronic pain and organ erosion and ,in some cases, sepsis.

Ethicon, owned by Johnson and Johnson, produced Gynecare TVT mesh.

The Panorama investigation reveals that one of Ethicon’s implants called the TVT-Secur implant, which was launched in 2006, was only tested on 31 women and sheep before being used in patients. It was later withdrawn from the market in 2012.

The investigation comes only a week after the death of Chrissy Brajcic, the first woman to have died from sepsis allegedly caused by mesh complications.

The vaginal mesh treatment involves implanting the netted mesh made from polypropylene into the vaginal wall. Over 10,000 women per year use the treatment in the UK.

The Panorama investigation comes amongst mounting pressure for vaginal mesh implants to be banned in the UK after many women suffered complications as a result of having it inserted into their body.

There has been growing concern that the side effects of having the mesh implanted can be more dangerous than previously believed.

Mounting evidence over the severe side effects and insufficient trialling has resulted in it being dubbed “the biggest scandal since Thalidomide,” referring to the morning sickness drug used in the 50s which caused birth defects.

Hundreds of thousands of women in the UK, US and Australia are currently involved in lawsuits against mesh producers with at least 800 in the UK suing the NHS.

Ethicon is also the subject of multiple class action law suits.

The company provides “instructions for use” leaflets with all its mesh products which have been designed to explain to doctors how to insert the mesh implants. The leaflets are also supposed to explain the risks associated with the surgery to help doctors explain the “adverse reactions” that some patients might develop after the surgery.

In the Panorama investigation, it will be revealed that in 2009, an associate medical director at Ethicon warned that the side effects detailed in the leaflets were insufficient as they described the side effects as “transitory”.

However many women have experienced lasting side effects after the surgery.

In an email sent in January 2009, the associate medical director suggested that the wording be changed in the leaflets, writing: “From what I see each day, these patient experiences are not ‘transitory’ at all.”

However, Panorama reveals that the instruction leaflets were not updated at the time. The most recent leaflets, which were updated in 2015, do outline that some effects may be permanent but use insufficient risk assessment data to do so.

Dr Wael Agur, a consultant urogynaecologist, told Panorama: “It’s so important for me as a surgeon to understand the full risks of a medical device I’m about to implant ... and my first resource would be the IFU.

“I would expect the manufacturer to have a comprehensive list of the adverse events and the risks within the instructions for use so I fully understand these and communicate them.”

Figures collected by Panorama revealed that NHS Digital and NHS Wales has implanted more than 130,000 women with mesh devices in the last decade.

In that same amount of time there have been 6,000 procedures to remove the implant.

In reality figures could be much higher as they do not include women who have had the mesh removed privately.

The Standard has reached out to Ethicon for further comment.

BBC Panorama: The Operation That Ruined My Life airs today on BBC One at 7.30pm

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